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This is a multi-centre Phase I trial of pre-operative, margin intensive, stereotactic body radiation therapy (SBRT) for previously untreated borderline resectable pancreatic cancer.

Study Design

Phase I rolling six design dose escalation study testing the use of Stereotactic Body Radiation Therapy (SBRT) delivered in the pre-operative setting for pancreatic cancers.

Primary Objectives

  • To establish the maximum tolerated dose (MTD) of margin-intensive SBRT delivered pre-operatively in the management of pancreatic cancer

Secondary Objectives:

  • To examine key clinical outcomes for patients treated with this regimen, namely:

      -     Surgical resection rates

      -     Resection margin status

      -     Response rates

  • Late SBRT toxicity (>1 month to 6 months post-surgery or to 6 months post SBRT for patients not proceeding to surgery)
  • Efficacy and long term safety of SBRT delivered pre-operatively in the management of pancreatic cancer

Key Dates

First site open to recruitment: 17 April 2015
Planned accrual completion: 17 April 2017
Trial duration: 39 months

Trial Publications

The study protocol publication can be found here.

A secondary results publication can be found here.